NeuralgiaNCT04700033
Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
A study testing Somatic IVR (sIVR) and Distractive IVR (dIVR) in people with Neuralgia and Spinal Cord Injuries, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuralgia, Spinal Cord Injuries, Chronic Pain
- What is being tested?
- Somatic IVR (sIVR) and Distractive IVR (dIVR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 5 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury survivors (chronic only)
- Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
- A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
- Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial
Who cannot join
- Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
- Head injuries causing cognitive or visual impairment
- Severe vertigo
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
Read the detailed description
When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.
- Conditions
- Neuralgia, Spinal Cord Injuries, Chronic Pain
- Being tested
- Somatic IVR (sIVR), Distractive IVR (dIVR), Control IVR (cIVR)
- Keywords
- Virtual Reality, Neuronal Plasticity, Neurological Rehabilitation, Immersive Virtual Reality
- Medical subject headings
- Neuralgia, Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatic IVR (sIVR)Device
This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally.
Distractive IVR (dIVR)Device
This intervention will consist of an IVR that is focused on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body.
Control IVR (cIVR)Device
This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial.
| Study group | Role | What they receive |
|---|---|---|
| Somatic IVR | Experimental | Participants with participate in Somatic IVR protocol three times per week for four weeks. Receives: Device: Somatic IVR (sIVR) |
| Distractive IVR | Active comparator | Participants with participate in Distractive IVR protocol three times per week for four weeks. Receives: Device: Distractive IVR (dIVR) |
| Control IVR | Placebo comparator | Participants with participate in Control IVR protocol three times per week for four weeks. Receives: Device: Control IVR (cIVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.
Measured: Up to 10 Weeks
Secondary outcomes (8)
User Experience Score (UES)
Participants rate their experience using the technology on a scale with a total score range of 0 to 10, where 0 means no enjoyment and 10 means very high levels of enjoyment.
Measured: 14 Days
Spinal Cord Independence Measure (SCIM III)
Spinal cord independence measure (SCIM III) measures the ability of patients with SCI to perform everyday tasks. SCIM is used for quantitative functional outcome assessment following interventions designed to promote recovery from spinal cord injury and to increase functional achievement; it covers 19 tasks in 16 categories, with a score range 0-100; all activities of daily living, grouped into four areas of function (subscales): Self-Care (scored 0-20), Respiration and Sphincter Management (0-40), Mobility in Room and Toilet (0-10), and Mobility Indoors and Outdoors (0-30). VR neurorehabilitation has shown to improve motor function as well as to reduce neuropathic pain in incomplete SCI patients. The study team is planning to monitor the effects that this IVR protocol has in motor recovery. Total score range for SCIM II is 0 - 100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Measured: Up to 10 Weeks
Numerical Pain Rating Scale (NPRS)
Users report the score of both neuropathic and other pain. The total score range is from 0 to 10, lowest score indicating 0, "No pain" and highest score indicating 10, "Pain as bad as it could be". The type of "other" pain will also be recorded (musculoskeletal, etc).
Measured: 16 Days
Beck Depression Inventory (BDI)
Beck Depression Inventory (BDI): Depression symptoms are estimated to be highly prevalent in SCI population and are associated with a myriad of negative outcomes including lower functional independence, and greater incidence of pain. This questionnaire is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Depression may be a major contributor to a lack of reduction of pain, the study team expects subjects with high BDI score may have worse results after the IVR. Total score range for BDI is 0 - 63; scores from 0 through 9 indicate no or minimal depression; from 10 through 18 indicate mild to moderate depression; from 19 through 29 indicate moderate to severe depression; and from 30 through 63 indicate severe depression.
Measured: Up to 10 Weeks
Patient's Global Impression of Change (PGIC)
Self-reported relieving effect: At the end of the treatment (post-intervention), the Patient's Global Impression of Change (PGIC) will evaluate both motor function and pain. The total score range includes no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7) as the highest score. The patients will answer the following question: "Since beginning treatment at this program, how would you describe the change (if any) in activity limitations, symptoms, emotions, and overall quality of life related to your condition?".
Measured: Up to 10 Weeks
Immersive Tendencies Questionnaire (ITQ)
Immersive tendencies questionnaire (ITQ): In the field of virtual reality, presence and immersion are standard measures of an individual's sense of engagement and involvement in an activity. The study team expects that high levels of immersion might indicate greater engagement and therefore reduction of the pain. Total score range for ITQ: 18 - 126.
Measured: Up to 10 Weeks
UQO- Presence Questionnaire (UPO-PQ)
The UQO Presence questionnaire (UQO-PQ): Presence can be a major factor that determines the quality and success of a virtual environment implementation. Several factors such as impression of being present, realness, and discomfort are measured in this questionnaire. The questionnaire has users rank the extent the agree with each question with the total score range of 0 - 100; the lowest score indicating 0 - "Not at all" and the highest score indicating 100- "Totally".
Measured: 16 Days
Neuropathic Pain Scale (NPS)
Neuropathic Pain Scale (NPS): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words.The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPS is 0 - 100, higher scores indicate more severity.
Measured: Up to 10 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start17 Jul 2019
- Primary completion5 May 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a single center, prospective randomized controlled clinical trial. The purpose of the study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PT, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700033
- Sponsor's protocol ID
- GCO 18-0891
- Status last verified
- Jun 2022
- First submitted
- 5 Jan 2021
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT04700033
- Acronym / sponsor ID
- GCO 18-0891
- Conditions
- Neuralgia, Spinal Cord Injuries, Chronic Pain
- Keywords
- Virtual Reality, Neuronal Plasticity, Neurological Rehabilitation, Immersive Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
Detailed description
When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is a single center, prospective randomized controlled clinical trial. The purpose of the study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
| Arm | Type | Receives |
|---|---|---|
| Somatic IVR | Experimental | Device: Somatic IVR (sIVR)Participants with participate in Somatic IVR protocol three times per week for four weeks. |
| Distractive IVR | Active comparator | Device: Distractive IVR (dIVR)Participants with participate in Distractive IVR protocol three times per week for four weeks. |
| Control IVR | Placebo comparator | Device: Control IVR (cIVR)Participants with participate in Control IVR protocol three times per week for four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Spinal cord injury survivors (chronic only)
- Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
- A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
- Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial
Key exclusion criteria (3 listed)
- Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
- Head injuries causing cognitive or visual impairment
- Severe vertigo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatic IVR (sIVR)This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally. | Device | Somatic IVR |
| Distractive IVR (dIVR)This intervention will consist of an IVR that is focused on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body. | Device | Distractive IVR |
| Control IVR (cIVR)This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial. | Device | Control IVR |
Primary outcome
Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Up to 10 Weeks
Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.
8 secondary outcomes
User Experience Score (UES)
Time frame: 14 Days
Spinal Cord Independence Measure (SCIM III)
Time frame: Up to 10 Weeks
Numerical Pain Rating Scale (NPRS)
Time frame: 16 Days
Beck Depression Inventory (BDI)
Time frame: Up to 10 Weeks
Patient's Global Impression of Change (PGIC)
Time frame: Up to 10 Weeks
Immersive Tendencies Questionnaire (ITQ)
Time frame: Up to 10 Weeks
UQO- Presence Questionnaire (UPO-PQ)
Time frame: 16 Days
Neuropathic Pain Scale (NPS)
Time frame: Up to 10 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Putrino, PT, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatic IVR (sIVR) and Distractive IVR (dIVR) in people with Neuralgia and Spinal Cord Injuries, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Symptom Inventory (NPSI) (time frame: Up to 10 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.